Design Inputs Form

Project Name: XXXX

DHF Number: XXXX

Scope

This document defines the foundation for the design and development of [Device Name], with a particular focus on the design inputs resulting from the translation of user requirements into technical requirements. These inputs establish the project’s device-related criteria, specifications, and constraints.

Project description

Replicate the content from the corresponding sections of the User Requirements document in this section, ensuring consistency and traceability.

Device description

XXX

Proposed intended use

XXX

Project framework

XXX

Design inputs

This section outlines the design inputs defined based on user-requirements that serve as the foundation for the design and development of the medical device.

Design inputs refer to the technical requirements derived from user needs. They translate the expectations and constraints expressed by the intended users, whether patients, healthcare professionals, or laypersons—into measurable specifications that guide the device’s design.

The objective of this section is to identify, categorize, and document the design inputs in a clear and traceable manner to ensure that the design outputs can be adequately verified against them. This process confirms that the device meets its defined technical specifications.

These design inputs also serve as the foundation for subsequent design activities, risk management processes, and ultimately, design verification.

The following subsections outline the various types of design inputs applicable to the device, each corresponding to a specific user requirement category.

These categories are provided for information and must be reviewed and customized to fit the specific context, use environment, and risk profile of the product under development.

Technical standards

A review of technical standards applicable to [Device Name] has been undertaken and the following standards have been found relevant to the definition of design inputs and/ design input specifications.

Standard	Standard description

Literature review and analysis

If literature review is conducted to define the design input and design input specifications.

A literature review was conducted to identify relevant published preclinical studies, including in vitro and in vivo investigations, as well as applicable bench tests. This review supported the identification of relevant design input parameters and corresponding technical specifications. The resulting information has been integrated into Section 4 Summary of user requirements. The full literature review and details of the analysis details are available in the Appendix X.

Testing

If tests have been performed before the design control phase to freeze the concept retained.

Prior to initiating the design control phase, a series of tests were conducted during the research phase to evaluate and select the most suitable device concept, as well as to identify critical design input parameters. The analysis of these tests enabled the definition of key technical specifications and design input criteria, which have been incorporated into Section 4 Summary of user requirements. The table below provides a list of the relevant tests performed.

Test report number	Test description

User survey

If user surveys have been sent to the user to obtain information from the field.

To confirm the technical specifications considered necessary by the intended users, user surveys were distributed to representative end users and the results were analyzed. This analysis supported the definition of key technical specifications and design input criteria, which have been incorporated into Section 4 Summary of user requirements. The user surveys and details of the analysis details are available in the Appendix X.

Device characterization

If benchmark tests are performed to gather objective technical data from comparable devices.

In order define the critical parameters and specifications based on similar devices, benchmark tests have been performed. These tests contribute to the definition of realistic and state-of-the-art design input parameters, aiding in the alignment of the new device with user expectations, regulatory requirements, and current market standards. This analysis of results supported the definition of key technical specifications and design input criteria, which have been incorporated into Section 4 Summary of user requirements. The device characterization results and details of the analysis details are available in the Appendix X.

XXX Describe additional topics as necessary

Summary of design inputs

The following table provides a structured summary of the design inputs defined based on the user requirements identified for this project. Each design input is described in measurable terms, associated with a clear acceptance criterion, and linked to its rationale or source. The defined verification method ensures that each design output can be objectively confirmed against the corresponding design input during the design verification phase. This table supports traceability throughout the design control process and serves as a foundational reference for subsequent design and development activities.

Based on the descriptions provided above, the specific design inputs relevant to this project must be clearly defined in the table below.

This table must be completed with the understanding that the description of each design input will directly guide its verification. Therefore, the wording must be precise and unambiguous to ensure the design outputs can be effectively verified against the design inputs.

#UR	Description	#DI	Design input description	Acceptance criteria	Source of AC	Design verification method
		#1.1
		#1.2
		#2.1
		#2.2
		#2.3

This table will serve as the foundation for establishing the traceability matrix for the design and development of [Device Name].

Approval

Revision	Date	Change History

Approval
Name
Position
Date
Signature

Appendix I – XXXXXX

Appendix II – XXXXXX